Understanding The UK's International Recognition Procedure

By Aashni Shah, Senior Specialist, Regulatory Affairs, and Dr. Claire Stevenson, Manager, Regulatory Affairs, PharmaLex

Since the UK exited the EU, regulatory processes have undergone significant transformations. One of the most impactful changes is the introduction of the International Recognition Procedure (IRP) by the Medicines and Healthcare products Regulatory Agency (MHRA) on January 1, 2024. Replacing the EC Decision Reliance Procedure, the IRP expands opportunities for faster market access by leveraging decisions from trusted regulatory partners.

The IRP offers two recognition pathways: Recognition A for recent approvals and Recognition B for approvals up to 10 years old, with specific eligibility criteria. Additionally, it supports post-approval processes, including variations and renewals. This streamlined approach reduces the regulatory burden on the MHRA and accelerates the availability of medicines for UK patients.

With its shorter approval timelines, the IRP enhances collaboration and positions the UK as a key player in global pharmaceutical regulation. Pharmaceutical companies aiming for faster market entry should explore the IRP's benefits.

Discover how this new procedure can benefit your business and ensure faster patient access to innovative therapies. Read on to learn more.